<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800039000413</udiDi>
    <basicUdiDi>B-08800039000413</basicUdiDi>
    <tradeName>Biotex</tradeName>
    <deviceName>Biotex</deviceName>
    <manufacturerName>Purgo Biologics Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000006105</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT4013</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:27:58.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800039000406</udiDi>
    <basicUdiDi>B-08800039000406</basicUdiDi>
    <tradeName>Biotex</tradeName>
    <deviceName>Biotex</deviceName>
    <manufacturerName>Purgo Biologics Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000006105</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT5016</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:27:57.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800039000390</udiDi>
    <basicUdiDi>B-08800039000390</basicUdiDi>
    <tradeName>Biotex</tradeName>
    <deviceName>Biotex</deviceName>
    <manufacturerName>Purgo Biologics Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000006105</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT4016</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:27:56.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800039000383</udiDi>
    <basicUdiDi>B-08800039000383</basicUdiDi>
    <tradeName>Biotex</tradeName>
    <deviceName>Biotex</deviceName>
    <manufacturerName>Purgo Biologics Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000006105</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT4016</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:27:53.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800039000376</udiDi>
    <basicUdiDi>B-08800039000376</basicUdiDi>
    <tradeName>Biotex</tradeName>
    <deviceName>Biotex</deviceName>
    <manufacturerName>Purgo Biologics Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000006105</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT3016</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:27:51.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800039000369</udiDi>
    <basicUdiDi>B-08800039000369</basicUdiDi>
    <tradeName>Biotex</tradeName>
    <deviceName>Biotex</deviceName>
    <manufacturerName>Purgo Biologics Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000006105</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT5019</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:27:51.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800039000352</udiDi>
    <basicUdiDi>B-08800039000352</basicUdiDi>
    <tradeName>Biotex</tradeName>
    <deviceName>Biotex</deviceName>
    <manufacturerName>Purgo Biologics Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000006105</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT4019</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:27:49.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800039000345</udiDi>
    <basicUdiDi>B-08800039000345</basicUdiDi>
    <tradeName>Biotex</tradeName>
    <deviceName>Biotex</deviceName>
    <manufacturerName>Purgo Biologics Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000006105</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT3019</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:27:47.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>00733132629954</udiDi>
    <basicUdiDi>B-00733132629954</basicUdiDi>
    <tradeName>00733132629954</tradeName>
    <deviceName>GORE-TEX® Suture</deviceName>
    <manufacturerName>W. L. Gore &amp; Associates, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001141</manufacturerSrn>
    <authorisedRepresentativeName>W.L. Gore &amp; Associates B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000168</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P6K23</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:21:15.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>00733132629947</udiDi>
    <basicUdiDi>B-00733132629947</basicUdiDi>
    <tradeName>00733132629947</tradeName>
    <deviceName>GORE-TEX® Suture</deviceName>
    <manufacturerName>W. L. Gore &amp; Associates, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001141</manufacturerSrn>
    <authorisedRepresentativeName>W.L. Gore &amp; Associates B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000168</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8M04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:21:14.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>00733132629930</udiDi>
    <basicUdiDi>B-00733132629930</basicUdiDi>
    <tradeName>00733132629930</tradeName>
    <deviceName>GORE-TEX® Suture</deviceName>
    <manufacturerName>W. L. Gore &amp; Associates, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001141</manufacturerSrn>
    <authorisedRepresentativeName>W.L. Gore &amp; Associates B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000168</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P6K25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:21:10.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>00733132629923</udiDi>
    <basicUdiDi>B-00733132629923</basicUdiDi>
    <tradeName>00733132629923</tradeName>
    <deviceName>GORE-TEX® Suture</deviceName>
    <manufacturerName>W. L. Gore &amp; Associates, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001141</manufacturerSrn>
    <authorisedRepresentativeName>W.L. Gore &amp; Associates B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000168</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P5K23</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:21:09.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>00733132629916</udiDi>
    <basicUdiDi>B-00733132629916</basicUdiDi>
    <tradeName>00733132629916</tradeName>
    <deviceName>GORE-TEX® Suture</deviceName>
    <manufacturerName>W. L. Gore &amp; Associates, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001141</manufacturerSrn>
    <authorisedRepresentativeName>W.L. Gore &amp; Associates B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000168</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P4K13</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:21:08.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>00733132629909</udiDi>
    <basicUdiDi>B-00733132629909</basicUdiDi>
    <tradeName>00733132629909</tradeName>
    <deviceName>GORE-TEX® Suture</deviceName>
    <manufacturerName>W. L. Gore &amp; Associates, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001141</manufacturerSrn>
    <authorisedRepresentativeName>W.L. Gore &amp; Associates B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000168</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>M2U28</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:21:07.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>00733132629893</udiDi>
    <basicUdiDi>B-00733132629893</basicUdiDi>
    <tradeName>00733132629893</tradeName>
    <deviceName>GORE-TEX® Suture</deviceName>
    <manufacturerName>W. L. Gore &amp; Associates, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001141</manufacturerSrn>
    <authorisedRepresentativeName>W.L. Gore &amp; Associates B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000168</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8M08</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:21:03.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>00733132629886</udiDi>
    <basicUdiDi>B-00733132629886</basicUdiDi>
    <tradeName>00733132629886</tradeName>
    <deviceName>GORE-TEX® Suture</deviceName>
    <manufacturerName>W. L. Gore &amp; Associates, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001141</manufacturerSrn>
    <authorisedRepresentativeName>W.L. Gore &amp; Associates B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000168</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8M06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:21:03.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>00733132629879</udiDi>
    <basicUdiDi>B-00733132629879</basicUdiDi>
    <tradeName>00733132629879</tradeName>
    <deviceName>GORE-TEX® Suture</deviceName>
    <manufacturerName>W. L. Gore &amp; Associates, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001141</manufacturerSrn>
    <authorisedRepresentativeName>W.L. Gore &amp; Associates B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000168</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8M02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:21:02.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>00733132629862</udiDi>
    <basicUdiDi>B-00733132629862</basicUdiDi>
    <tradeName>00733132629862</tradeName>
    <deviceName>GORE-TEX® Suture</deviceName>
    <manufacturerName>W. L. Gore &amp; Associates, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001141</manufacturerSrn>
    <authorisedRepresentativeName>W.L. Gore &amp; Associates B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000168</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8K10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:21:01.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>00733132629855</udiDi>
    <basicUdiDi>B-00733132629855</basicUdiDi>
    <tradeName>00733132629855</tradeName>
    <deviceName>GORE-TEX® Suture</deviceName>
    <manufacturerName>W. L. Gore &amp; Associates, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001141</manufacturerSrn>
    <authorisedRepresentativeName>W.L. Gore &amp; Associates B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000168</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8K08</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:20:57.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>00733132629848</udiDi>
    <basicUdiDi>B-00733132629848</basicUdiDi>
    <tradeName>00733132629848</tradeName>
    <deviceName>GORE-TEX® Suture</deviceName>
    <manufacturerName>W. L. Gore &amp; Associates, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001141</manufacturerSrn>
    <authorisedRepresentativeName>W.L. Gore &amp; Associates B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000168</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201010501</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8K02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:20:56.759Z</lastUpdated>
  </row>
</eudamedExport>